{"paper_id":"137e8ac8-f8e8-47cb-bbff-51ad2e66ce40","body_text":"ORIGINAL ARTICLE\nEfficacy of ovarian suspension to round ligament\nwith a resorbable suture to prevent postoperative\nadhesions in women with ovarian endometrioma:\nfollow-up by transvaginal hydrolaparoscopy\nMassimiliano Pellicano & Pierluigi Giampaolino &\nGiovanni Antonio Tommaselli& Ursula Catena &\nCarmine Nappi & Giuseppe Bifulco\nReceived: 22 January 2014 / Accepted: 7 July 2014\n# Springer-V erlag Berlin Heidelberg 2014\nAbstract The aim of this study was to assess the effect of\novarian suspension to the round ipsilateral ligament with a\nresorbable suture, performed during laparoscopic surgery for\nendometrioma, on postoperative ovarian adhesion formation.\nThe tool used to assess this effect was not conventional\nlaparoscopy but outpatient transvaginal hydrolaparoscopy.\nFifty women with single ovarian endometrioma were divided\nin two groups (group A, 24 and group B, 26). All patients\nunderwent laparoscopic ovarian cystectomy for endometri-\nosis. In group A, the ovary was suspended to the ipsilateral\nround ligament. In group B, ovarian suspension was not\nperformed. All patients underwent transvaginal outpatient\nhydrolaparoscopy as follow-up. A significantly lower rate of\npostsurgical ovarian adhesion in group A in comparison with\ngroup B (33.3 vs 80.8 %—p=0.001) was observed. Operative\ntime and postoperative pain were similar in both groups.\nOvarian suspension to the ipsilateral round ligament with a\nresorbable suture during surgery for endometrioma is associ-\nated with a lower rate of postoperative ovarian adhesion\nformation.\nKeywords Endometrioma . Laparoscopy . Ovarian\nsuspension . Adhesion prevention . Transvaginal\nhydrolaparoscopy\nBackground\nOvarian endometriomas are a form of ovarian endometriosis,\nclassified as cysts within the ovaries [1] accounts for 35 % of\nbenign ovarian cysts [ 2], and are present in 17 –44 % of\npatients with endometriosis. Expectant management is not\nan option for women with endometrioma because of severe\nsymptoms [1].\nOperative laparoscopy is the first-line treatment option\navailable to the general consensus in the treatment of\nendometriomas >3 cm. However, debate still continues on\nthe type of laparoscopic procedure. The main point of debate\nis excision or ablation of the cyst capsule [ 3, 4]. Since the\novarian endometrioma is a pseudocyst, excisional surgery\ninvolves the removal of ovarian cortex with primordial folli-\ncles, reducing the fertility potential of the affected ovary,\nespecially when extensive hemostasis irreversibly diminishes\nor impairs the blood supply towards the affected ovary. Ovar-\nian cystectomy for endometriomas seems to cause significant\ndamage to ovarian reserve with up to 40 % fall in serum AMH\nconcentration [5, 6]. According to Donnez et al., cystectomy\nmay be destructive for the ovary, whereas ablation may be\nincomplete with a greater risk of recurrence [ 7]. With the\ncombined technique (excision of a large part of endometrioma\nwall with vaporization of the remaining 10 –20 % of\nendometrioma wall close to the hilus), we achieve the benefits\nof stripping on symptoms and recurrence, and a less harmful\neffect of ablation on ovarian reserve.\nAdhesions formation rate after laparoscopic endometriosis\nsurgery has been reported in more than 80 % cases [8–11]. The\nmost common site of postoperative adhesions formation is\nbetween the ovary and the pelvic wall [ 12]. Notwithstanding\nthe advances in surgical techniques [13] and the use of surgical\nM. Pellicano: P . Giampaolino: G. A. Tommaselli: U. Catena (*) :\nC. Nappi : G. Bifulco\nDepartment of Obstetrics and Gynaecology, University of Naples,\n“Federico II”, Via Pansini 5, 80131 Naples, Italy\ne-mail: ursula.catena@gmail.com\nDOI 10.1007/s10397-014-0854-4\nGynecol Surg (2014) 11:261–266\n/ Published online: 1 20147        July             \n\nanti-adhesive agents, the incidence of adhesion-related compli-\ncations do not seem to have significantly declined [14].\nThe aim of this study was to assess the effect of ovarian\nsuspension to the round ipsilateral ligament with a resorbable\nsuture, during laparoscopic surgery for endometrioma in terms\nof postoperative ovarian adhesions after surgical procedure\nevaluated with office transvaginal hydrolaparoscopy.\nMethods\nThis study was performed in the Infertility Clinic of our\nDepartment. During the period from March 2010 to March\n2012, 185 women affected by endometriosis were evaluated\nfor inclusion in the study. Inclusion criteria were: age between\n1 8a n d4 0y e a r s ;h i s t o r yo fi nfertility >2 years; single\nendometrioma cysts ≥4o r ≤7c m[ 15]o np r e o p e r a t i v eu l t r a -\nsound screen. Patients with smaller endometriomas were ex-\ncluded because treatment of endometriomas of 1 –3c mw a s\nrecommended only for the treatment of pain. When endome-\ntriosis is identified at laparoscopy, it is recommended to sur-\ngically treat endometriosis, as this is effective for reducing\nendometriosis-associated pain [ 16]. In these cases, we per-\nformed drainage and coagulation of the endometrioma wall\nbecause of the possible difficulty in the removal of very small\ncysts, due to the absence of a clear surgical plane.\nExclusion criteria were: masses occupying the Douglas\npouch; previous surgery for endometriosis or additional con-\ncomitant surgical procedure planned during the laparoscopic\nprocedure; current pregnancy, including ectopic pregnancy;\nserum glutamic-oxaloacetic transaminase (sgot), serum gluta-\nmate pyruvate transaminase (sgpt), and/or bilirubin >20 %\nabove the upper limit of the normal range; azotemia and\ncreatinine >30 % above the upper limit of the normal range;\nconcurrent use of systemic corticosteroids, antineoplastic\nagents, and/or radiation; and active pelvic or abdominal\ninfection.\nThe study was approved by the Institutional Review\nBoards of our Institution and all patients gave informed con-\nsent to participate in the study. Eighty-three patients matched\nthe inclusion criteria and agreed with the study protocol, 21\nhowever refused to participate to the study. Sixty-two patients\nwere divided into two groups (group A, n=31; group B, n=\n31). Patients in group A underwent ovarian suspension to\nround ligament, while patients in group B did not undergo\nadditional procedures other than that indicating laparosocopy.\nBoth patients and surgeons performing THL were blinded\nwith regard to which cases had their ovaries suspended and\nwhich cases did not.\nThe laparoscopic procedure was performed in the modified\ndorso-lithotomic position under endotracheal general anesthe-\nsia. After pneumoperitoneum induction with a V eress needle\nand introduction of a 10-mm laparoscope (Karl Storz —\nTuttlingen, Germany) in the standard umbilical position, three\n5-mm trocars were placed i n the following positions:\nsuprapubic, left iliac fossa, and right iliac fossa. After careful\nexploration of the pelvic organs and upper abdomen, patients\nwith single endometrioma adherent to the ipsilateral fossa\nwere included, while patients with clinical evidence of cancer,\nrectovaginal endometriosis or bilateral endometriosis were\nexcluded.\nLight adhesions on the controlateral adnexa and/or small\nsubserousal uterine myomas observed at first surgery were not\nconsidered as exclusion criteria. Ovarian endometriomas were\nremoved following the technique described by Donnez [ 7].\nBriefly, the ovarian cyst was opened and its content drained,\nthe cleavage plane was found and the pseudo-capsule was\nseparated from the ovarian parenchyma by means of repeated\ndiverging traction applied with atraumatic forceps. Light co-\nagulation with bipolar forceps was performed only if neces-\nsary, exclusively inside the ovarian parenchyma, before clo-\nsure of the ovary. The suture was performed using a single\nrunning suture with an absorbable monofilament suture\n(Vicryl Rapid 2.0, CT-1 needle, Sommerville, NJ, USA,\nEthicon) with intraovarian knots. Ovarian suture was per-\nformed so that no coagulated tissue was detectable outside\nas previously reported [ 13]. In group A, the ovary was\nsuspended to the ipsilateral round ligament using an absorb-\nable monofilament suture (Vicryl Rapid 2.0, CT-1 needle,\nSommerville, NJ, USA, Ethicon). The suture was performed\napproximately 1 cm from the inguinal canal, to separate the\novary approximately 1.5–2 cm from the ovarian fossa (Fig.1).\nIn group B, ovarian suspension was not performed.\nThe operation time was calculated from the induction of\npneumoperitoneum to desufflation. Blood loss during surgery\nwas estimated by measuring the aspirated blood volume.\nSurgery was performed with an indwelling Foley catheter in\nsitu that was removed as soon as the patient could indepen-\ndently reach the toilet. Twenty-four hours after the procedure,\nFig. 1 Ovarian suspension to round ligament\n262 Gynecol Surg (2014) 11:261–266\n\npostoperative pain was evaluated using a pain visual\nanalogue scale (V AS) ranging from 0 (absence of pain)\nto 10 (maximum pain). Per protocol, patients were\ndischarged from the hospital 2 days after the procedure\nif no complication arose during the postoperative period.\nAll patients were evaluated 60 –90 days after surgery\nwith transvaginal outpatie nt hydrolaparoscopy (THL).\nTHL was not performed before because patients may\nnot agree to undergo a second invasive procedure im-\nmediately after the initial surgery.\nTransvaginal hydrolaparoscopy was performed by three\nsurgeons: M.P . who performs approximately 100 procedures\nper year; U.C. and P .G. who perform about 25 procedures per\nyear. Fertiloscopy was performed under local anesthesia with\nthe patient in the lithotomic position. A Collin’ss p e c u l u mw a s\nplaced in the vagina and a local anesthetic solution containing\nmepivacaine hydrochloride 3 % was injected in the posterior\nfornix, 1–2 cm below the cervix and on the posterior lip of the\ncervix which was grasped. A specially designed needle dilat-\ning trocar system with a total diameter of 3.9 mm (reusable\nsystem by Karl Storz Endoscopy—Tuttlingen, Germany) was\nplaced 10–20 mm below the insertion of the posterior vaginal\nwall to the cervix. A 2.7-mm-diameter semi- rigid endoscope\nwas used with an optical angle of 30°. The correct intra-\nabdominal trocar position was confirmed visually, and a slow\ncontinuous infusion of warmed saline solution was started [17,\n18]. To keep the bowel and tubo-ovarian structures afloat the\nillumination was provided by a high-intensity cold-light\nsource via fiber-optic lead. The images were viewed on\nhigh-resolution color monitor. The posterior wall of the uterus\nwas inspected. Subsequently, by rotation and deeper insertion\nof the scope, the tubo-ovarian structures were visualized.\nSuccess was defined as the absence of any adhesion between\nthe ovary and the ovarian fossa (Fig. 2). The vaginal fornix\nwas left to close spontaneously, and antibiotic prophylaxis\nwas prescribed.\nThe primary end-point was the proportion of women with-\nout ovarian adhesions as evaluated by THL 60-90 days after\nthe primary surgical procedure. We hypothesized that women\nunderwent ovarian suspension would develop ovarian adhe-\nsion in 30 % of cases as opposed to 70 % of women not\nundergoing this procedure. Considering these proportions, we\ncalculated that we would need a sample size of 24 in group A\nand 24 in group B to give 90 % power to detect a significant\ndifference between ovarian suspension and non ovarian sus-\npension procedures with a one-sided type 1 error of 5 %. To\naccount for loss to follow-up, we chose to enroll 31 patients in\ngroup A and 31 in group B. Secondary end-points were\noperative times, intra-operative blood loss, and intra- and\npostoperative complication rate.\nStatistical analysis was performed using the Statistical\nPackage for Social Science, version 15.0 (SPSS, Chicago,\nIL, USA). Data distribution for continuous variables was\nassessed with the Shapiro –Wilk’s test. Difference in propor-\ntions between groups for the primary end-point was analyzed\nusing the χ2 test and the odds ratios were calculated. Student’s\nt test for unpaired samples was used to compare parametric\nvariables between groups. The Mann-Whitney test was used\nto analyze differences in non parametric parameters between\ngroups. Analysis was performed both per protocol and on an\nintention-to-treat basis. Separate analysis was carried out con-\nsidering all drop-outs as having formed adhesions (failures) or\nnot having formed adhesions (successes) between the ovary\nand its fossa. Significance was set for a value of p<0.05 .\nFindings\nCharacteristics of patients are listed in Table 1. No statistical\ndifferences were observed in any variable between the two\ngroups. In group A, three patients were excluded intraopera-\ntively from the study for the presence of contralateral ovarian\nadhesions at laparoscopy and one patient for the presence of\nFig. 2 Transvaginal hydrolaparoscopy follow-up\nTable 1 Characteristics of patients. V alue are given as mean±SD or\nmedian [range], as appropriate p=NS for all comparisons\nGroup A\n(n=31 )\nGroup B\n(n=31 )\nAge (years) 26.5±16.5 28.2±15.8\nWeight (kg) 63.1±8.9 62.2±10.5\nHeight (cm) 170.3±35.6 172.2±28.2\nBMI (cm) 25.2±3.5 23.2±2.9\nPrimary infertility 21 (67.7) 23 (74.2)\nEndometrioma diameter (cm) 5.2±1.1 6.1±2.1\nHb (g/dl) 12.3±1.5 13.1±2.1\nHospital stay (days) 2.2±2[2 –4] 2.1±2 [2 –3]\nOperative time (min) 65.6±9.8 62.1±8.5\n263Gynecol Surg (2014) 11:261–266\n\ntwo ovarian cysts; in group B three patients were excluded for\nendometriosis stages III–IV (ASRM).\nFive patients (three from group A and two from group B)\ndropped out of the study: one patient was pregnant to follow-\nup, two patients refused to undergo THL, and in two patients\nTHL was not possible to perform for poor compliance (pain in\nthe positioning of speculum or trocar in the posterior fornix).\nThus, a total of 24 women in group A and 26 women in\ngroup B were available for the analysis. In all the 50 proce-\ndures, it was possible to enter the pelvic cavity and visualize\nthe pouch of Douglas.\nAt the THL control, a significant higher proportion of\npatients for group A were free of adhesions in comparison\nwith patients from group B (Table 2; p=0.001). Analyses\nconsidering all patients as failures (i.e., with adhesions forma-\ntion between the ovary and its fossa) or success (i.e., non\nadhesions formation) confirmed that ovarian suspension leads\nto a significantly higher proportion of patients who did not\ndevelop adhesions (Table 2).\nWe did not observe any difference in terms of postoperative\npelvic pain between the two groups, according to V AS scale\n(4.78±1.48 in group A vs 4.05±1.67 in group B; p<0.16 ).\nThe operating time was similar between group A and group\nB( p=0.11). No major complications (rectum perforation)\nwere reported in both groups. At follow-up, no ovary was still\nsuspended to the round ligament; in all patients from group A,\nthe ovary was found in its anatomical location.\nDiscussion\nEndometriosis is a complex and heterogeneous condition\ncharacterized by a continuous state of inflammation that\ncauses symptoms of pelvic pain and infertility. In this condi-\ntion, fibrosis and adhesions are common. Some authors sup-\nport that the inflammatory response may be the first cause of\nadhesion formation [19]. It leads to an upregulation of tissue\nfactors by peritoneal cells and local macrophages. This causes\nactivation of the extrinsic pathway of the coagulation cascade\nand the formation of an exudate rich in fibrin [19]. Adhesions\ncan lead to infertility, dyspareunia, chronic pelvic pain, and\ncomplications at repeated surgery [ 20, 21]. Adhesions may\nproduce disruption of the normal anatomy, thus altering nor-\nmal tubal performance. Thus, follicular growth, pick-up of the\noocyte after ovulation and spermatozoa or embryo transport\nm a yb ei m p a i r e d[20]. Several women develop postoperative\nadhesions after laparoscopy surgery. The most common site of\npostoperative adhesions formation is the ovary [ 12, 22]. Al-\nthough several surgical measures and systemic pharmacologic\ntreatments for adhesions prevention have been proposed, the\nrate of periovarian adhesion formation was not significantly\nreduced [ 13, 20–22]. The high incidence of postoperative\nadhesions in endometriosis patients and their clinical signifi-\ncance underline the importance of modifying surgical tech-\nnique in order to reduce potential adhesion formation.\nAdhesions may develop in locations previously unaffected\n(de novo) or in locations where adhesiolysis was performed\n(recurrence). The process of adhesions formation begins dur-\ning surgery; the possible development of adhesions is deter-\nmined within the first 7 days of the injury. In the injured area, a\ngel matrix of fibrin will form and macrophages recruit new\nmesothelial cells over the damaged surface which reaches the\nreconstruction of the mesothelial lining within 5–7 days. The\nadhesions will take place if the surfaces damaged remain in\ncontact [ 23, 24]. This finding supports the idea of an\novariopexy.\nSeveral authors previously proposed ovarian suspension\ntechniques [25–30]( T a b l e3). The technique most frequently\ndescribed has been temporary ovarian suspension to anterior\nabdominal wall [25–28]. This technique showed only limited\nresults, with success rates ranging from 80 to 40 %. Moreover,\nthis technique carries potential risks of infection due to the\nproximity of the ovary to the external abdominal wall. Only\none author reported [ 26] an ovarian suspension to the round\nligament, showing no dense adhesion of the ovary to the\npelvic sidewall after definitive ovarian suspension to the\nround ligament. These results are in accordance with our\nTa bl e 2 Rate of postsurgical ad-\nhesions between patients treated\nwith ovarian suspension (group\nA) and patients treated without\novarian suspension (group B)\nGroup A Group B OR (95 %CI) p\nAnalysis per protocol n=24 n=26 0.119 (0.03 –0.55) 0.001\nPostoperative ovarian adhesion formation 8 (33.3 %) 21 (80.8 %)\nNo postoperative ovarian adhesion 16 (66.7 %) 5 (19.2 %)\nConsidering all drop-outs as failures n=27 n=28 0. 14 9 (0.04 –0.60) 0.002\nPostoperative ovarian adhesion formation 11 (40.7 %) 23 (82.1 %)\nNo postoperative ovarian adhesion 16 (59.3 %) 5 (17.9 %)\nConsidering all drop-outs as successes n=27 n=28 0. 14 0 (0.04 –0.53) 0.001\nPostoperative ovarian adhesion formation 8 (29.6 %) 21 (75 %)\nNo postoperative ovarian adhesion 19 (70.4 %) 7 (25 %)\n264 Gynecol Surg (2014) 11:261–266\n\nfindings. The main drawback of previous analysis was the\nsignificant loss to follow-up. Indeed, in all previous studies,\nsecond-look surgery was performed only in a small number of\npatients (Table 3), since systematic laparoscopic second-look\nmay be frequently refuted by patients. In this study, we used\nan office-based procedure performed under local anesthesia\nthat should increase the compliance of patients in undergoing\nfollow-up second-look.\nIndeed, only five patients refused to undergoing second-\nlook with THL, supporting this hypothesis. This is to our\nknowledge, the first study using V ycril Rapid to suspend the\novary to the round ligament. Because development of adhe-\nsion is determined within the first 5 –7 days after surgery, we\nprefer to use Vicryl Rapid 2.0 suture for its characteristics loss\nof tensile strength in 5 –7 days and fast reabsorption process.\nThe ovary so remains separated from the peritoneum of the\novarian dimple for about 7 days, the time necessary for adhe-\nsions formation. In the present study, no significant difference\nwas observed in terms of operative time.\nMoreover, we did not observe a difference in terms of\npostoperative pain evaluated according to V AS scale. We\nbelieve that no difference in postoperative pain between the\ntwo groups is linked to the ovarian suspension technique used.\nWe suspend the ovary approximately 1.5 cm from ovarian\nfossa with tension-free suture.\nThis study has several advantages. It can rely on effec-\ntive blinding of the surgeon performing THL, so that a\nbias in determining adhesion formation is unlikely. More-\nover, it was correctly powered to detect significant differ-\nences between the two groups. Finally, sensitivity analysis\nwas performed to address differences in losses to follow-\nup in the two arms. A potential limitation of the study\nmay be the nonrandomized design of the study that may\nlead to an allocation bias. Nevertheless, the population\nselected for the study was homogeneous, so that differ-\nences in the two groups are unlikely. Another potential\nlimitation is the low external validity due to strict inclu-\nsion criteria. These criteria were chosen in order to eval-\nuate the net effect of the proposed technique on adhesion\nformation rate due to the suturing of the ovary, avoiding\ninterference of other factors.\nProspective comparative studies including more patients\nshould be conducted to confirm our preliminary results.\nIn conclusion, this study seems to indicate that ovarian\nsuspension to the round ligament with short-term resorbable\nsuture may be a simple and effective surgical technique for the\nprevention of periovarian adhesion formation and could be\nincluded into the routine surgical procedure for single\nendometrioma. Moreover, THL can be considered to be a\nsimple and minimally invasive technique with a good com-\npliance for the postoperative follow-up, to evaluate adhesion\nformation.\nConflict of interest Massimiliano Pellicano, Pierluigi Giampaolino,\nGiovanni Tommaselli, Ursula Catena, Carmine Nappi and Giuseppe\nBifulco declare that they have no conflict of interest.\nEthical standards All procedures followed were in accordance with\nthe ethical standards of the responsible committee on human experimen-\ntation (institutional and national) and with the Helsinki Declaration of\n1975, as revised in 2000. Informed consent was obtained from all patients\nfor being included in the study.\nReferences\n1. Benschop L, Farquhar C, van der Poel N, Heineman MJ (2010)\nInterventions for women with endometrioma prior to assisted repro-\nductive technology. Cochrane Database Syst Rev 10(11):CD008571\n2. 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